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NCT00407888 · ClinicalTrials.gov registry record · Phase 2

Doxorubicin Hydrochloride, Cyclophosphamide, and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery

A Phase 2 study, sponsored by University of Washington.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target

NCT00407888 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 60 participants.

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The verdict

NCT00407888, a Phase 2 study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy and filgrastim together with trastuzumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel albumin-stabilized nanoparticle formulation and trastuzumab works in treating patients with breast cancer previously treated with surgery

Interventions

  • DRUG cyclophosphamide
  • BIOLOGICAL trastuzumab
  • DRUG paclitaxel albumin-stabilized nanoparticle formulation
  • BIOLOGICAL filgrastim
  • DRUG doxorubicin hydrochloride

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2006-05
Est. Completion 2012-07
Phase Phase 2

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT00407888

The ClinicalTrials.gov registry entry for NCT00407888 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00407888 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00407888 about?

NCT00407888 is a clinical study titled "Doxorubicin Hydrochloride, Cyclophosphamide, and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery". RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors,...

What is the current status of trial NCT00407888?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2006-05. Estimated completion is 2012-07.

What interventions are being tested in trial NCT00407888?

The interventions under investigation include: cyclophosphamide (DRUG), trastuzumab (BIOLOGICAL), paclitaxel albumin-stabilized nanoparticle formulation (DRUG), filgrastim (BIOLOGICAL), doxorubicin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00407888?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.